DEVICE: WAW SOFTWARE (05430003362068)
Device Identifier (DI) Information
WAW SOFTWARE
0.1.35
In Commercial Distribution
Devroye Instruments Belgium
0.1.35
In Commercial Distribution
Devroye Instruments Belgium
The WAW Duo FUE System is intended for Follicular Unit Extraction (FUE) with the aim to harvest hair follicles
by preserving hair integrity (amount of hair per follicle and hair quality) for further hair graft implantation. This
is done by optimizing hair transplant for both the receiver (increasing quality of the recipient area with respect
to naturalness and density) and the donor (taking care of the donor region).
The WAW Duo FUE System is composed of the following:
- The WAW Wireless Handpiece:
o Composed of a motor and a battery, and a detachable cleanable (via autoclave) external
sleeve
o Connected via Bluetooth to the tablet
o Responsible for the rotation and oscillation movements of the punch (not included) for the
FUE,
- The WAW Wired Handpiece, a backup solution for the WAW Wireless Handpiece:
o Cleanable (via autoclave)
o Connected via a wire to the pedal
o Responsible for the rotation and oscillation movements of the punch for the FUE,
- The WAW Pedal, responsible for activating the handpieces,
- The WAW Software, responsible for defining the parameters of functioning (rotation and
oscillation movement) of the handpieces and mode (manual, semi-auto, auto or continuous) of the
pedal (the Samsung tablet is supplied),
- The WAW Charging Station, intended to recharge the wireless handpiece and
- The External Sleeve Support Box, intended to sustain external parts of WAW Wireless
Handpiece and WAW Wired Handpiece during autoclave process.
- Assembly tools: 3 mounting tools to assemble and disassemble the handpieces.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
44680 | Electrosurgical handpiece, reusable |
A hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to the generator; it is not intended for use during inert gas-enhanced electrosurgery. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GEY | Motor, Surgical Instrument, Ac-Powered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Atmospheric Pressure: between 50 and 105 KiloPascal |
Handling Environment Humidity: between 10 and 65 Percent (%) Relative Humidity |
Handling Environment Temperature: between 10 and 40 Degrees Celsius |
Storage Environment Atmospheric Pressure: between .5 and 1.05 KiloPascal |
Storage Environment Humidity: between 10 and 65 Percent (%) Relative Humidity |
Storage Environment Temperature: between -5 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3211bfc3-48c7-4d99-a84d-5c284263f0b0
May 19, 2025
1
May 09, 2025
May 19, 2025
1
May 09, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+3208807064
info@devroyeinstruments.com
info@devroyeinstruments.com